The Impact of Positioning on Bottle-feeding in Preterm Infants. A Comparative Study PMMHHRI-2018/V/9-SZB

Sponsor

Polish Mother Memorial Hospital Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04773613

Collaborator

(none)

Enrollment

Location

Arms

21.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

One of the challenges of modern neonatology is to identify the right and effective method that can improve oral feeding. Optimal feeding position may contribute to improving the quality and safety of bottle-feeding in premature infants.

Condition or Disease	Intervention/Treatment	Phase
Bottle Feeding Premature	Other: Experimental SLP Other: Experimental SEP	N/A

Detailed Description

PURPOSE: The aim of the study was to compare the advantages of semi-elevated (SEP) with side-lying positioning (SLP) during bottle-feeding of preterm infants.

METHOD: The study included forty two neonates (n=42) born ≤34 weeks of gestational age. Four bottle-feeding sessions were tested in each of the newborns: two in the SEP and two in the SLP. The position for the first study was randomly assigned, then positioning changed after each feeding session. In one day, only two consecutive feeding sessions which were included to the study in order to minimize fatigability as a disrupting factor. The levels of saturation (SpO2) and heart rate (HR) were measured as the parameters indicative of the newborn's physiological stability. The factors determining the qualitative aspect of feeding included the total time of declines of SpO2 ≤85%, level of the newborn's alertness according to the Neonatal Behavioral Assessment Scale (NBAS), and the occurrence of choking episodes. The proportion of milk consumed (volume of milk eaten relative to the expected volume) and the duration of the feeding and feeding session were also recorded.

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

The Impact of Positioning on Bottle-feeding in Preterm Infants ≤34 Gestational Age. A Comparative Study of the Semi-elevated and Side-lying Position

Actual Study Start Date :

Jul 19, 2018

Actual Primary Completion Date :

Apr 20, 2020

Actual Study Completion Date :

Apr 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental SLP Infant placed in a SLP on the researcher's lap. Head of the infant symmetrically placed between the shoulders, supported by the researcher's. Shoulder girdle higher than the pelvic girdle, head and back in a straight line - a slight natural bend of the body is allowed. Legs bent at an angle of approx. 90° in the natural flexion of the knee and ankle joint. The infant's arms close to the midline (on the bottle or researcher's hands)	Other: Experimental SLP SLP was given to the infant during bottle-feeding.
Other: Experimental SEP Infant placed in a SEP on the researcher's lap. The head rests on the researcher's hand. Shoulder girdle higher than the pelvic girdle, head and back in a straight line at an angle of 30-45° to the ground - slight, natural body bend is allowed. Legs bent at an angle of approx. 90° in the natural flexion of the knee and ankle joint. The infant's arms close to the midline (on the bottle or researcher's hands)	Other: Experimental SEP SEP was given to the infant during bottle-feeding.

Arm

Intervention/Treatment

Experimental: Experimental SLP

Infant placed in a SLP on the researcher's lap. Head of the infant symmetrically placed between the shoulders, supported by the researcher's. Shoulder girdle higher than the pelvic girdle, head and back in a straight line - a slight natural bend of the body is allowed. Legs bent at an angle of approx. 90° in the natural flexion of the knee and ankle joint. The infant's arms close to the midline (on the bottle or researcher's hands)

Other: Experimental SLP

SLP was given to the infant during bottle-feeding.

Other: Experimental SEP

Infant placed in a SEP on the researcher's lap. The head rests on the researcher's hand. Shoulder girdle higher than the pelvic girdle, head and back in a straight line at an angle of 30-45° to the ground - slight, natural body bend is allowed. Legs bent at an angle of approx. 90° in the natural flexion of the knee and ankle joint. The infant's arms close to the midline (on the bottle or researcher's hands)

Other: Experimental SEP

SEP was given to the infant during bottle-feeding.

Outcome Measures

Primary Outcome Measures

Physiological stability [Measured 2 minutes before feeding session, in 3rd and 10th minutes of feeding, at the moment of finish of the feeding and in 10th minute after feeding (5 points of measurement)]
Oxygen saturation (SpO2) changes measured by using a pulse oximeter data
Physiological stability [Measured 2 minutes before feeding session, in 3rd and 10th minutes of feeding, at the moment of finish of the feeding and in 10th minute after feeding (5 points of measurement)]
Heart rate (HR) changes measured by using a pulse oximeter data
Qualitative aspect of bottle-feeding [Measured during feeding]
Total time of declines of SpO2 ≤85%
Qualitative aspect of bottle-feeding [Measured 2 minutes before feeding session, in 3rd and 10th minutes of feeding, at the moment of finish of the feeding and in 10th minute after feeding (5 points of measurement)]
Level of the newborn's alertness changes according to the 6-point Neonatal Behavioral Assessment Scale, where individual points mean: 1 - quiet sleep, 2 - active sleep, 3 - drowsy, 4 - quiet alert, 5 - active alert, 6 - crying. This is descriptive, qualitative scale which shows changes of newborn's activity.
Qualitative aspect of bottle-feeding [Noticed during feeding]
Occurrence of choking episodes
Qualitative aspect of bottle-feeding [Measured from taking the baby out of bed before feeding to putting the baby to bed immediately after the intervention. Putting baby on parent's chest to kangaroo (Kangaroo Mother Care) after feeding instead to bed was also allowed.]
Duration of the feeding session
Qualitative aspect of bottle-feeding [Measured from insertion of the nipple to the infant's mouth to the moment when baby finish the feeding]
Duration of feeding
Qualitative aspect of bottle-feeding [Measured in 10th minute of feeding and on the finish of the feeding (2 points of measurement)]
Proportion of milk consumed (volume of milk eaten relative to the expected volume)

Eligibility Criteria

Criteria

Ages Eligible for Study:

32 Weeks and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

circulatory and respiratory stability;
readiness for oral feeding according to each child's Speech-Language Pathologist assessment;
prematurely born infants who were in the process of being transferred from enteral nutrition (or enteral nutrition + parenteral nutrition) to full oral feeding and were fed orally at least 4- 6 times within twenty-four hours;
parents gave informed consent to participate their infant in the study.

Exclusion Criteria:

disorders which could significantly affect the feeding course, such as cleft lip and/or palate, facial paralysis and/or congenital defects of the facial skeleton;
the presence of detected congenital abnormalities and metabolic diseases; low Apgar score (less than 5 points at the 5th and 10th minute of the measurement);
administered analgesics, anticonvulsants and sedatives;
<72 hours from extubation prior the trial;
parents refusal to participate in the study or when bottle-feeding was not the parental preference.